Hypodermic syringe assembly

ABSTRACT

Prefilled cartridges assembled and packaged for mixing of dual ingredient hypodermic injections immediately prior to injection. Package may also be employed for prefilled cartridge of single ingredient.

United States Patent Fieldol'Search 218, 218 (M), 218 (P), 218 (PA),218.], 219, 220, 221, 272; 206/632, 43; 128/218 (N.V.)

Paul E. Paulson 2015 Wales Road N.E., Massillon, Ohio 44646 Oct. 6, 1967Feb. 16, I971 HYPODERMIC SYRINGE ASSEMBLY 6 Claims, 4 Drawing Figs.

US. Cl

7 206/632; 128/218; 206/43 Int. Cl A61m 5/22; B65d 77/08 l5 l6 Ad 28Primary Examiner- Richard A. Gaudet Assistant ExaminerChanning L. PaceAttorney-Ely & Golrick ABSTRACT: Prefilled cartridges assembled andpackaged for mixing of dual ingredient hypodermic injections immediatelyprior to injection. Package may also be employed for prefilled cartridgeof single ingredient.

' KAY HYPODERMIC SYRINGE ASSEMBLY This invention relates to hypodermicsyringe assemblies employing sterile prefilled cartridges containingmeasured dosages of medicines to be administered as a hypodermicinjection. More particularly, this invention relates especially to suchassemblies comprising a plurality of ingredients which are maintained inseparate sterile cartridges for mixing just prior to injection.

To satisfy both governmental control measures and the internal qualitycontrols of drug manufacturers, the prefilling in sterile cartridges ofmedicinal dosages intended to be administered by hypodermic injectionhas been widely adopted. When the medicine is a single ingredient or maybe mixed from several ingredients and thus safely stored, it has alsobecome a standard practice to package the prefilled dosage in disposablehypodermic syringes, rather than the physicians or patients reusablesyringe. Such single-case disposable syringes provide the opportunityfor optimum sterility, accuracy of dosage, comfort of injection (due tothe absence of dulling the needle through reuse), and, by saving thetime of the physician or patient in resterilizingreused syringes,economy is also obtained.

It is an object of the invention to provide a syringe assembly so thatthe foregoing advantages may be obtained for dosages of ingredientswhich cannot be packaged and stored as a single dosage but must be mixedat or administered shortly after mixture. Many of the newer medicines,particularly many antibiotics, are most safely or conveniently stored ina form which prevents them from being administered until mixed withanother ingredient or diluent; thereafter, they will deteriorate if notadministered promptly.

It is also an advantage of this invention that, in achieving the aboveobject, one may use standard cartridges of the separated ingredients andthe manipulation to mix and inject the dosage are ones which arefamiliar and similar to the manipulation of conventional syringes inadministering hypodermic injections.

It is another object and advantage of this invention to provide forsterile packaging of the entire assembly which may be usedadvantageously for a single'component syringe assembly as well as aduel-component assembly.

Other objects and advantages of this invention will be apparent from thefollowing specification, claims, and drawings in which:

FIG. 1 is a cross section of a preferred dual-cartridge syringe assemblymade according to the invention and packaged for shipping and storage.

FIG. 2 is a view similar to FIG. 1, but showing the assembly removedfrom its package and at a first stage of assembly for preparing formixing.

FIG. 3 is a view similar to FIG. 2, but showing the final stage ofassembly for mixing.

FIG. 4 is a view showing the syringe containing the mixed dosage readyfor injection.

As shown in.,FlG. l, the complete package for a dual component,premasured dosage, prepared for shipping and storage, employs a primarycartridge made up of a vial 11, preferably prpvided with a manipulatingflange 12. The dosage of one ingredient A, usually a liquid in theprimary cartridge, is sterilely packed in the vial 11 between a sealingplunger 13 and puncturable diaphragm 14, both usually of rubber. Thediaphragm 14 is held on the neck of the vial 11 by a crimped metal band15. As thus described, the cartridge 10 is of a standard type, approvedby governmental agencies for sterile packaging of hypodermicallyadministered dosages when packaged under approved conditions withapproved equipment.

The plunger 13 is provided with a threaded or other connection 16 to aplunger stem 17 having a diameter which permits reciprocation of thestern in the vial 11 with a guiding and sliding fit. The outer end ofthe stem 17 has a cap 18, preferably molded integrally with the stem andhaving a flanged recess 19 (See FIGS. 2-4). To lock the plunger and stem17 to prevent accidental dislodgement during shipment and handling priorto intensive manipulating for administration, the stem 17 is providedwith notches 51 located in the stem according to the volume of theingredient A so that, when packaged as in FIG. 1, the notches 51 will bejust outside the flange 12. A U- shaped clip 50 having an extendedfinger 52 located at the base of the U and bent in a plane perpendicularto the plane of the U, is snapped onto the assembled plunger stem andflange so that the flange is engaged by the finger 52 while the stem isengaged by the clip 50, received inthe notches 51. As indicated in FIGS.3 and 4, the notches 51 may be fonned by a circumferential groove in thestem 17.

The secondary cartridge 20 is comprised of a vial 21, in this casepreferably but not necessarily flangeless, which carries a dosage of thesecond ingredient B sterilely packaged between a plunger 23 and adiaphragm 24 sealed by a band 25 similar to the corresponding elements13, 14, and 15 in the primary cartridge 10. In the secondary cartridge,however, the stem 26, connected at its inner end to the plunger 23, isprovided with a longitudinal needle-receiving bore 22 provided, at itsouter end, with a pair of needle-coupler engaging ridges 27 and 28extending inwardly into the bore 22. The stem is preferably molded of aslightly elastic plastic with an enlarged integral flange 29.

As indicated in FIG. 1, the cartridges 10 and 20 are coupled forpackaging and shipping by a needle-bearing coupler 30 comprised of abarrel 31 closed at its inner end, which is provided with an extendingshank 32 Aneedle 33 is molded and permanently secured in the shank 32, arelatively short outer portion extending into the barrel 31 of thecoupler and relatively long inner portion extending through the bore 22of the stem 26 up to the plunger 23. The interior of the barrel 31 isprovided with a snap ridge 35, which engages the inner end of thesealing band 15 as the neck of the vial 11 is inserted in the barrel 31.The barrel 31 preferably receives the vial 11 with a fairly firmfrictional fit so that the ridge 35 serves as a firm (though notpositive) stop when the cartridges are assembled, as in FIG. 1. Theshank 32 is provided with grooves 38 which receives the ridge 28 of thestem 26 so that the innermost end of the shank 32 is received betweenthe ridges 27 and 28 and, thereby, is held firmly but not positively inthe bore 22 of the stem 26, as shown in FIG. 1.

It will be noted in FIG. 1 that the radius of the plunger stem flange 29is about equal to the radius of the vial stem 12 plus the thickness ofthe finger 52 of the clip 50 and the diameter of the flange 29 is justslightly less than the diameter of the recess 19 of the cap 18 on theprimary plunger stem 17. So proportioned, the assembly of the cartridgesl0 and 20 is adapted to be received in a closed end packing tube 53which closely fits on the recess 19 of the plunger cap 18; this fit maybe frictional but is preferably provided with a seal which maintains thesterility of the assembly within the tube 53 and which would be rupturedwhen the assembly is removed for use. The assembly is thus supported andcentered within the packing tube 53 by the cap 18, the clip 50 and, atthe center, by the flange 29. Due to the firm fit of the coupler barrel31 upon the vial l1 and the firm latching of the coupler shank 32 in thebore 22, the assembly will withstand rough handling in shipping andstorage up to loads which the tube 53 can withstand. A small packingring (not shown) may be placed in the tube 53 adjacent its closed end toreceive the neck of the vial 20, but this appears to be a surplusage.

To manipulate and administer an admixture of dosages A and B, theassembled vials are removed from the shipping tube 53, and, with theclip 50 still in place, the flange 29 is held while pressure is appliedto the cap 18. This will push the vial 11 into the barrel 31 of thecoupler 30, snapping the ridge 35 over the band 15 to a locking positionbetween the band and the neck of the vial 11, as shown in FIG. 2. Abruptconfigurations of the mating surfaces of the band 15 and ridge 35 canmake this position a substantially permanently locked arrangement whichis difficult to dislodge without rupturing the assembly and, in anyevent, an assembly adequate to withstand any normal loads which mightthereafter tend to dislodge the cartridge 10 from the coupling 30 duringuse. The significance of the lock secured by the coupler 30 on thecartridge 10 is that the movement of the vial 11 into the barrel 31drives the outer end of the hypodermic needle 33 through the diaphragml4 and into the dosage A; thus the lock of the coupler 30 on thecartridge 10 substantially permanently affixes the needle 33 to thecartridge to and in communication with the interior of the vial ll.

Simultaneously with the coupling of the coupler 30 on the cartridge 10,or quickly following it, the same longitudinal force which locks thecoupler 30 on the cartridge 10 forces the shank 33 further into the bore22 of the stem 26, disengaging the ridge 28 from the groove 38 andtelescoping the shank into the bore 22 until the ridge 27 snaps into thegroove 38 to effect a removable latching of the stem 26 on the shank 32while the inner end of the needle 33 pierces the plunger 23 and entersthe volume of the cartridge 20 containing the dosage B.

With the assembly held in the same manner as it is held to force thecoupling of the cartridges l and 20 with the coupler 30, as indicated inFIG. 2, the clip 50 is removed. Continued pressure on the cap 18 therebyforces the contents of the primary cartridge into the secondarycartridge 20, causing the plunger 23 and stem 26 to move outwardly ofthe via] 21 and mixing dosages A and B within the via] 21.

Further mixing is achieved by withdrawing the plunger 13 to aspirate themixed dosage in the vial 21 into the vial 11. The stem 26 is then pulledoff the coupler 30 and the mixed dosage A and B is then ready to beadministered hypodermically, as indicated in FIG. 4. v

The above embodiment of this invention has been described in detail inits preferred form as an assembly for administering a mixed dosage ofseparately packaged ingredients. It is to be understood, of course, thatthe same principle may be applied in packaging for an admixture of threeingredients (or more) by adding a duplicate (or more) of the coupler 30and cartridge onto the coupler and cartridge as shown in FIG. 1.Further, without the vial 21, the stem 26 can serve as a needle coverfor a single dosage packaged in the cartridge 10 which may carry theneedle coupler 30.

Likewise the cartridge 10 and coupler may be replaced with aconventional syringe in which the hypodermic needle, either held on thesyringe neck by a close-fitting ferrule or permanently received in theglass neck of the syringe, is in communication with the inside of thesyringe when it is assembled in the hollow stem 26. In such cases thelength of the bore 22 is preferably proportioned with respect to thelength of the needle so that the point of the needle is buried in thesealing plunger 23 but does not penetrate it until the stem 26 isfurther telescoped onto the needle. Contents of the syringe may then beexpelled and mixed in a cartridge 20, as in FIG. 3 or other package, andthe mixed contents may then be aspirated back into the syringe forinjection after the stem 26 and cartridge vial have been removed anddiscarded.

Accordingly, this invention is not to be limited to the preferredembodiment disclosed; rather it may be varied to meet specific needs orconditions within the scope of the following claims.

lclaim:

l. A hypodermic needle assembly comprising a first cartridge including afirst-necked vial having a dosage sealed therein, said seal beingeffected by a rupturable diaphragm and an outer sealing band closing thevial neck and a stemoperated plunger within said vial; a stem member anda coupler comprising a barrel fitting over the necked end of said vial,an integral shank extending beyond said barrel, a hypodermic needlecarried by said shank and having an end extending into said barrel, anddetent means within said barrel, said detent means normally engagingsaid sealing band to space the end of said needle from said diaphragmbut to lock said coupler onto said cartridge by engaging said band whenthe vial is forced past said detent means further into said barrel,including a longitudinal cylindrical plunger stem member having a boreextending throughoutits length and receiving said shank and a protrudingend of said needle, and means to normally restrain said stem member onsaid shank and space the same from said barrel while the protruding endof said needle is located substantially entirely in said bore.

2. A hypodermic needle assembly as defined in claim 1 including asecondary cartridge comprised of a vial and containing a dosage sealedin said vial by a plunger connected to said cylindrical stem member,whereby said needle may be forced into communication between the dosagesof said first and second cartridges by telescoping said coupler on thevial of said first cartridge and said stem member onto said shank topierce the diaphragm of the seal and of said first cartridge .with

one end of said needle and the plunger of said second cartridge with theprotruding end of said needle.

3. A hypodermic needle assembly as defined in claim 2 including a stemconnected to the plunger of said first cartridge, a flange on the vialof said first cartridge, and removable clip means to engage said stemand said flange simultaneously in order to fix the position of saidplunger in said vial.

4. A hypodermic needle assembly as defined in claim 3 including a cap onsaid plunger stem of said first cartridge and a rigid packaging membersurrounding said assembly as defined in claim 4 and closed by said cap,whereby the said assembly may be supported for shipping and stored in asterile condition with said packaging member.

5. A packaged hypodermic needle assembly as defined in claim 5 in whichsaid plunger stem member of said second cartridge is provided with aflange whose radius is substantially equal to the radius of said clipmeans and but slightly less than the radius of said cap, whereby saidpackaging means may be a tube closed at one end and adapted to be closedby said cap at its other end and said flange on said plunger stem memberwill support said assembly within said tube.

6. A spacer-plunger stem for hypodermic needle assemblies comprising atubular member flanged at one end and provided at its other end withmeans connected to a plunger in a hypodermic dosage vial, the externalsurface of said stem having a sliding fit within said vial, and detentmeans on the interior of the bore of said tubular stem engaging aferrule portion of means carrying a hypodermic needle having an overalllength greater than the length of said bore but restrained by saiddetent means, when inserted into said bore at the flanged end of saidstem, from penetrating through the plunger on said other end of saidstem.

1. A hypodermic needle assembly comprising a first cartridge including afirst-necked vial having a dosage sealed therein, said seal beingeffected by a rupturable diaphragm and an outer sealing band closing thevial neck and a stem-operated plunger within said vial; a stem memberand a coupler comprising a barrel fitting over the necked end of saidvial, an integral shank extending beyond said barrel, a hypodermicneedle carried by said shank and having an end extending into saidbarrel, and detent means within said barrel, said detent means normallyengaging said sealing band to space the end of said needle from saiddiaphragm but to lock said coupler onto said cartridge by engaging saidband when the vial is forced past said detent means further into saidbarrel, including a longitudinal cylindrical plunger stem member havinga bore extending throughout its length and receiving said shank and aprotruding end of said needle, and means to normally restrain said stemmember on said shank and space the same from said barrel while theprotruding end of said needle is located substantially entirely in saidbore.
 2. A hypodermic needle assembly as defined in claim 1 including asecondary cartridge comprised of a vial and containing a dosage sealedin said vial by a plunger connected to said cylindrical stem member,whereby said needle may be forced into communication between the dosagesof said first and second cartridges by telescoping said coupler on thevial of said first cartridge and said stem member onto said shank topierce the diaphragm of the seal and of said first cartridge with oneend of said needle and the plunger of said second cartridge with theprotruding end of said needle.
 3. A hypodermic needle assembly asdefined in claim 2 including a stem connected to the plunger of saidfirst cartridge, a flange on the vial of said first cartridge, andremovable clip means to engage said stem and said flange simultaneouslyin order to fix the position of said plunger in said vial.
 4. Ahypodermic needle assembly as defined in claim 3 including a cap on saidplunger stem of said first cartridge and a rigid packaging membersurrounding said assembly as defined in claim 4 and closed by said cap,whereby the said assembly may be supported for shipping and stored in asterile condition with said packaging member.
 5. A packaged hypodermicneedle assembly as defined in claim 5 in which said plunger stem memberof said second cartridge is provided with a flange whose radius issubstantially equal to the radius of said clip means and but slightlyless than the radius of said cap, whereby said packaging means may be atube closed at one end and adapted to be closed by said cap at its otherend and said flange on said plunger stem member will support saidassembly within said tube.
 6. A spacer-plunger stem for hypodermicneedle assemblies comprising a tubular member flanged at one end andprovided at its other end with means connected to a plunger in ahypodermic dosage vial, the external surface of said stem having asliding fit within said vial, and detent means on the interior of thebore of said tubular stem engaging a ferrule portion of means carrying ahypodermic needle having an overall length greater than the length ofsaid bore but restrained by said detent means, when inserted into saiDbore at the flanged end of said stem, from penetrating through theplunger on said other end of said stem.